Akash A
Director - GxP Computer Systems Management at TRACON Pharmaceuticals | Oakland, California, United States
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As the Director of GxP Computer Systems Management at TRACON Pharmaceuticals, Akash A. plays a pivotal role in ensuring that all computerized systems comply with stringent regulatory frameworks and industry best practices. With extensive experience in pharmaceutical GxP computerized system validation, Akash is adept at navigating the complexities of compliance, particularly in the context of FDA regulations and GAMP guidelines. His expertise encompasses the entire lifecycle of system management, from initial conception and implementation to retirement, ensuring that each phase adheres to the highest standards of quality oversight.
One of Akash's key projects includes leading the validation of regulated systems, such as Software as a Service (SaaS) platforms and custom in-house applications. His strategic approach has resulted in the successful implementation of a robust computer system compliance strategy, which is integral to TRACON's data integrity program. Notably, he has developed an efficient process for evaluating Veeva mandatory product updates, ensuring that the organization remains compliant with evolving regulatory requirements while minimizing disruption to operations.
In addition to his technical acumen in areas such as Chromatography, HPLC, and Laboratory Information Management Systems (LIMS), Akash is a self-motivated team player who fosters collaboration across departments. His commitment to risk-based testing and adherence to Annex 11 guidelines further underscores his dedication to maintaining the integrity and reliability of computerized systems. Through his leadership, Akash not only enhances operational efficiency but also strengthens TRACON's position as a leader in the pharmaceutical industry, ensuring that all systems are not only compliant but also optimized for future growth.
Director - GxP Computer Systems Management at TRACON Pharmaceuticals in May 2021 to Present
Sr. Manager, IT Quality at PRA Health Sciences in October 2018 to May 2021
Director Of Compliance at goBalto, Inc. in August 2015 to May 2018
Sr Validation Specialist at Bayer HealthCare in July 2012 to August 2015
Sr. Validation Engineer at Genentech in June 2010 to June 2012
CSV Consultant at Genentech, Medimmune, Schering Plough in October 2005 to June 2010
Systems Analyst (CSV) at Amgen in June 2004 to October 2005
Laboratory Systems Administrator at Shire Pharmaceuticals in June 2001 to June 2004
QC and Research Chemist at Shire Pharmaceuticals in September 1997 to June 2001
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21 CFR Part 11
Computer System Validation
GAMP
Sop
Validation
GMP
Chromatography
HPLC
FDA
GLP
Change Control
CAPA
V&V
LIMS
SOP
Quality Assurance
FDA GMP
Software as a Service (SaaS)
U.S. Title 21 CFR Part 11 Regulation
annex 11
EMA
21 CFR
Good Clinical Practice (GCP)
GLPs
pic/s
Computerized System Validation (CSV)
Change Management
Risk Based Testing
Vendor Management
Internal Audit
External Audit
Software Quality Assurance
High-Performance Liquid Chromatography (HPLC)
Laboratory Information Management System (LIMS)
excel validation
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Discover more about TRACON PharmaceuticalsWhat is Akash A email address?
Email Akash A at [email protected]. This email is the most updated Akash A email found in 2026.
How to contact Akash A?
To contact Akash A send an email to [email protected]. (updated on September 13, 2024)
What company does Akash A work for?
Akash A works for TRACON Pharmaceuticals
What is Akash A's role at TRACON Pharmaceuticals?
Akash A is Director - GxP Computer Systems Management
What is Akash A's Phone Number?
Akash A's phone (213) ***-*261
What industry does Akash A work in?
Akash A works in the Biotechnology Research industry.
Akash A Email Addresses
Akash A Phone Numbers
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